Splenectomy
Conditions
Brief summary
The primary end point is the mean log-titre over the three meningococcal strains (NZ98/254 for PorA, 5/99 for NadA and 44/76-SL for fHbp) as measured by the hSBA one month after second vaccination. The non-inferiority margin was set to a 2-fold titre difference between the geometric mean titre of the asplenic group and the healthy control group.
Detailed description
The persistence of antibodies will be measured six months after second vaccination and the difference between the means of the log-titers between the asplenic and the control group will be calculated., The cellular immune response as measured by lymphocyte proliferation assay and cytokine levels., Adverse events (AEs) during the observation period will be tabulated by single events with the number of the vaccination, the type of the event, its severity and evaluation concerning its relation to the vaccination, potential treatment and sequelae.
Interventions
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary end point is the mean log-titre over the three meningococcal strains (NZ98/254 for PorA, 5/99 for NadA and 44/76-SL for fHbp) as measured by the hSBA one month after second vaccination. The non-inferiority margin was set to a 2-fold titre difference between the geometric mean titre of the asplenic group and the healthy control group. | — |
Secondary
| Measure | Time frame |
|---|---|
| The persistence of antibodies will be measured six months after second vaccination and the difference between the means of the log-titers between the asplenic and the control group will be calculated., The cellular immune response as measured by lymphocyte proliferation assay and cytokine levels., Adverse events (AEs) during the observation period will be tabulated by single events with the number of the vaccination, the type of the event, its severity and evaluation concerning its relation to the vaccination, potential treatment and sequelae. | — |
Countries
Austria
Outcome results
None listed